Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH (NCT02976012) | Clinical Trial Compass
UnknownPhase 1/2
Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH
United States24 participantsStarted 2016-06
Plain-language summary
This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) \<21 days but \>7 days prior to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults age \>18 years with Diabetes Mellitus
✓. PDR- related vitreous hemorrhage and not of another cause
✓. BCVA Vision LP or better
✓. Investigator determination that vitrectomy indicated for PDR-related vitreous hemorrhage
✓. Willing and able to comply with clinic visits and study-related procedures
✓. Provide HIPPA and signed informed consent prior to any study procedures
Exclusion criteria
✕. A condition per investigator opinion, would preclude participation in the study (unstable medical status, cardiovascular disease, glycemic control, inability to follow up etc.)
✕. Participation in an investigational trial within 30 days of enrollment
✕. Known allergy to IAI
✕. Systemic anti-VEGF or pro-VEGF treatment within 4 months of enrollment
✕. For women of childbearing age, pregnant or lactating or intending to become pregnant within the next 3 years
✕. History of PRP or peripheral retinal cryopexy or peripheral retinopexy for any reason in the study eye
✕. History of vitrectomy in the study eye
What they're measuring
1
• Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks: